ORAVERSE Drug Patent Profile

When do Oraverse patents expire, and when can generic versions of Oraverse launch?

Oraverse is a drug marketed by Septodont Holding and is included in one NDA.

The generic ingredient in ORAVERSE is phentolamine mesylate. There are four drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the phentolamine mesylate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Oraverse

A generic version of ORAVERSE was approved as phentolamine mesylate by HIKMA on March 11^th, 1998.

Summary for ORAVERSE

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	110
Clinical Trials:	6
Patent Applications:	1,014
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for ORAVERSE
What excipients (inactive ingredients) are in ORAVERSE?	ORAVERSE excipients list
DailyMed Link:	ORAVERSE at DailyMed

See drug prices for ORAVERSE

Recent Clinical Trials for ORAVERSE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Cairo University	Phase 3
sara nabil	Phase 3
Dalhousie University	Phase 4

See all ORAVERSE clinical trials

Pharmacology for ORAVERSE

Drug Class	alpha-Adrenergic Blocker
Mechanism of Action	Adrenergic alpha-Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for ORAVERSE

C04AB	Imidazoline derivatives
C04A	PERIPHERAL VASODILATORS
C04	PERIPHERAL VASODILATORS
C	Cardiovascular system

V03AB	Antidotes
V03A	ALL OTHER THERAPEUTIC PRODUCTS
V03	ALL OTHER THERAPEUTIC PRODUCTS
V	Various

US Patents and Regulatory Information for ORAVERSE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Septodont Holding	ORAVERSE	phentolamine mesylate	INJECTABLE;INJECTION	022159-001	May 9, 2008		RX	Yes	Yes

Expired US Patents for ORAVERSE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Septodont Holding	ORAVERSE	phentolamine mesylate	INJECTABLE;INJECTION	022159-001	May 9, 2008
Septodont Holding	ORAVERSE	phentolamine mesylate	INJECTABLE;INJECTION	022159-001	May 9, 2008
Septodont Holding	ORAVERSE	phentolamine mesylate	INJECTABLE;INJECTION	022159-001	May 9, 2008
Septodont Holding	ORAVERSE	phentolamine mesylate	INJECTABLE;INJECTION	022159-001	May 9, 2008

International Patents for ORAVERSE

See the table below for patents covering ORAVERSE around the world.

Country	Patent Number	Title	Estimated Expiration
Mexico	PA04012507	FORMULACIONES ESTABILIZADAS PARA ANTOAGONISTAS DEL RECEPTOR ALFA-ADRENERGICO Y USOS DE LAS MISMAS. (STABILIZED FORMULATIONS OF ALPHA ADRENERGIC RECEPTOR ANTAGONISTS AND USES THEREOF.)
China	1688312	Stabilized formulations of alpha adrenergic receptor antagonists and the uses thereof
Cyprus	1107617
Australia	5984801